Chapter 1. Introductory provisions
1 §/expires U: 2016-01-01/
This regulation contains provisions relating to fees
According to section 25 of the medicines Act (1992:859).
1 section/entry into force: 01/01/2016
This regulation provides for the fees referred to in chapter 15. the medicines Act (2015:315).
Regulation (2015:465).
2 §/expires U: 2016-01-01/
The terms and expressions used in pharmaceutical law
(1992:859) has the same meaning in this regulation.
In addition, '
1. natural remedies: medicinal products where the active
components have a natural origin, are not
overly processed and constitutes an animal, bacterial culture,
mineral or salt solution and that is only appropriate for
self care in accordance with the well proven domestic tradition
or tradition in countries with respect to
drug use is Sweden near,
2. some topical medications: medications for the treatment of
simpler diseases in humans and animals, such as
wound ointments, inhaled the oils, antiseptic solutions,
liniments and the like, where the active
components have a well-established medicinal use
with recognised efficacy and an acceptable level of safety,
3. parallel imports: imports into Sweden from a country in the
European economic area (EEA) of a
drugs that are approved for sale in Sweden and in
the country of export, which is managed by someone other than the manufacturer
or the marketing authorisation holder,
4. stock preparation: a standardized medicines that do not
is approved for sale and produced by a
pharmacies,
5. license: authorization to sell a drug under paragraph 5 of the
the third paragraph of the medicines Act,
6. the national license: a license in respect of a stock preparation,
7. duplikatansökan: an application relating to an approval
for sale that completely corresponds to an existing
approval or another application for approval except when
the case of the name of the medicinal product and marketing
marketing authorisation,
8. duplicates: drugs that have been approved on the basis of a
duplikatansökan and which still represents
the reference medicine except for name and holders
of the marketing authorization,
9. major variation of type II: modification which is not a
expanded approval which may have a significant impact on
the quality, safety or efficacy of the medicinal product,
10. Ce certificate for batch release: document
Specifies that an official statement release regarding
vaccines and blood products for human use has taken place prior to the
release on the Swedish market,
11. abridged application: application for approval for
sales on the basis of documentation for a
reference medicinal product pursuant to section 8(a) of the medicines Act,
12. approval or registration under the
decentralised or mutual procedure when
Sweden is concerned Member State: an approval or a
registration based on the reference Member State
basis for application of the decentralized
procedure or the recognition of an authorisation or
registration in another State of the European
economic area,
13. request to Sweden to work as
the reference Member State in a decentralised or
reciprocal procedure: request to Sweden to work
as the reference Member State in a decentralised procedure
According to § 6 d medicines Act or to the FDA
shall prepare or complete an assessment report in
connection with application in another Member State for recognition
of a in Sweden announced the approval or registration.
2 section/entry into force: 01/01/2016
The terms and expressions used in the medicines Act (2015:315) has the same meaning in this regulation. In addition, '
1. natural remedies: medicinal active ingredient (s) has a natural origin, are not too processed and constitutes an animal, bacterial culture, mineral or salt solution and that is only appropriate for self-management in accordance with well proven domestic tradition or traditions in countries with respect to the use of drugs is Sweden near,
2. some topical medications: medications for the treatment of diseases in humans and animals, such as ulcer ointments, inhaled the oils, antiseptic solutions, liniments and the like, where the active substances have a well-established medicinal use with recognised efficacy and an acceptable level of safety,
3. parallel imports: arrival to Sweden from a country within the European economic area (EEA) of a drug that is approved for sale in Sweden and in the export country, which is managed by someone other than the manufacturer or the holder of the marketing authorisation,
4. stock preparation: a standardized drug that is not approved for sale and made by a pharmacy,
5. license: authorization to sell a drug pursuant to Chapter 4.
section 10, second paragraph the medicines Act,
6. the national license: a license in respect of a stock preparation,
7. duplikatansökan: an application for a marketing authorisation that completely corresponds to an existing approval or another application for approval except for the name of the medicinal product and the holders of the existing authorisation,
8. duplicates: medicinal products authorised for sale after a duplikatansökan and still correspond to the reference product, except for the name and owner of the existing authorisation,
9. major variation of type II: modification that is not an extension of the marketing authorisation and which may have a significant impact on the quality, safety or efficacy of the medicinal product,
10. Ce certificate for batch release: a document that indicates that an official statement release regarding vaccines and blood products for human use has taken place prior to release on the Swedish market,
11. abridged application: the application for marketing authorisation on the basis of the documentation of a reference medicinal product pursuant to Chapter 4. section 13 medicines Act,
12. the authorisation or registration in accordance with the decentralised or mutual procedure when Sweden are affected Member country: an authorisation or a registration for sale based on the reference member country's input in the implementation of the decentralised procedure or a recognition of an authorisation or a registration granted in another country within the EEA,
13. request to Sweden to act as reference Member State in a decentralised or mutual procedure: request for Sweden to act as reference Member State in a decentralised procedure pursuant to Chapter 4. § 9 the medicines Act or agency shall develop or complete an assessment report in connection with the application in another Member State for recognition of an authorisation or a registration granted in Sweden. Regulation (2015:465).
section 3 of the FDA hears questions about fees according to
This regulation.
section 4 of the Fee to be charged in the cases set out in this
Regulation.
Chapter 2. Application fees
Authorisation of medicinal products for sale
section 1 the fee for an application for authorisation of medicinal products for
the sale shall be paid as follows:
1. medicinal products for Human use
a) complete application, with the exception of the b-h 400 000 kr
b) application relating to a generic medicine
the reference medicinal product is not authorised in the
Sweden 400 000 kr
c) application for a radiopharmaceutical 65 000 kr
d) application relating to an allergen 65 000 kr
e) application designed herbal remedies or
some topical medications 100 000 kr
f) abridged application in cases where
the reference medicine authorised in Sweden 200 000 kr
g) duplikatansökan 30 000 kr
h) application designed parallel imported
medicine 25 000 kr
2. Medicinal products for veterinary use
a) complete application, with the exception of (b) – (f) 200 000 kr
b) application relating to a generic medicine
the reference medicinal product is not authorised in the
Sweden 200 000 kr
c) application designed herbal remedies or
some topical medications 50 000 kr
d) abridged application in cases where
the reference medicine authorised in Sweden 100 000 kr
e) duplikatansökan 15 000 kr
f) application designed parallel imported
medicine 12 500 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name submitted
for the assessment at the same time. The fee for the application for
parallel imported medicinal products as referred to in the first subparagraph 1 (h)
and (f) concerned all the strengths and pharmaceutical forms
with the same drug name from the same country as
submitted for assessment at the same time.
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Approval of medicines for sale under the
decentralised or mutual procedure when
Sweden is the Member State concerned
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Approval of medicines for sale under the decentralised or mutual procedure when Sweden are affected Member country
2 §/expires U: 2016-01-01/
Fee for the application for the authorisation of medicinal products for
sale under the decentralized or it
reciprocal procedure when Sweden are Member State concerned
shall be paid as follows:
1. medicinal products for Human use
a) complete application, with the exception of (b) – (d) 100 000 kr
b) application relating to a generic medicine
the reference medicinal product is not authorised in the
Sweden 100 000 kr
c) abridged application in cases where
the reference medicine authorised in Sweden 65 000 kr
d) duplikatansökan 30 000 kr
2. Medicinal products for veterinary use
a) complete application, with the exception of (b)-(d) € 5,000
b) application relating to a generic medicine
the reference medicinal product is not authorised in the
Sweden 50 000 kr
c) abridged application in cases where
the reference medicine authorised in Sweden 32 500 kr
d) duplikatansökan 15 000 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name submitted
for the assessment at the same time.
2 section/entry into force: 01/01/2016
The fee for an application for the approval of medicines for sale under the decentralised or mutual procedure when Sweden are affected Member country shall be paid as follows:
1. Medicinal products a) complete application, with the exception of (b) – (d) 100 000 kr
b) application for a generic medicinal product, the reference medicinal product is not authorised in Sweden 100 000 kr
c) abridged application in cases where the reference medicine authorised in Sweden 65 000 kr
d) duplikatansökan 30 000 kr
2. veterinary medicinal products a) complete the application, with the exception of (b)-(d) € 5,000
b) application for a generic medicinal product, the reference medicinal product is not authorised in Sweden 50 000 kr
c) abridged application in cases where the reference medicine authorised in Sweden 32 500 kr
d) duplikatansökan 15 000 kr
The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. Regulation (2015:465).
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Extension of an existing authorisation
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Extension of an existing authorisation
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Fee for the application for extension must
be paid as follows:
1. medicinal products for Human use
(a) the application for extension), with
the exception of (b) and (c) 200 000 kr
b) application for extension relating to the
natural remedies or some topical medications 50 000 kr
c) application for recognition of an enlarged
approval in accordance with the decentralised or
the reciprocal procedure when Sweden are
Member State concerned 65 000 kr
2. Medicinal products for veterinary use
(a) the application for extension), with
the exception of (b) and (c) 100 000 kr
b) application for extension relating to the
natural remedies or some topical medications 50 000 kr
c) application for recognition of an enlarged
approval in accordance with the decentralised or
the reciprocal procedure when Sweden are
Member State concerned 32 500 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name submitted
for the assessment at the same time and for the same type
by amending the conditions for authorisation.
3 section/entry into force: 01/01/2016
The fee for an application for the extension of the marketing authorisation shall be paid as follows:
1. Medicinal products a) application for extension, with the exception of (b) and (c) 200 000 kr
b) application for extension relating to herbal remedies or some topical medications 50 000 kr
c) application for recognition of an extension under the decentralised or mutual procedure when Sweden are affected Member country 65 000 kr
2. veterinary medicinal products (a)) the application for extension, with the exception of (b) and (c) 100 000 kr
b) application for extension relating to herbal remedies or some topical medications 50 000 kr
c) application for recognition of an extension under the decentralised or mutual procedure when Sweden are affected Member country 32 500 kr
The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time and the same type of modification of the conditions for approval. Regulation (2015:465).
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Registration of herbal medicinal products and
extension of such registration
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Registration for the sale of traditional herbal medicinal products and extension of such registration
4 §/expires U: 2016-01-01/
The fee for an application for registration of a
traditional herbal medicinal product shall be paid in accordance with the
the following:
1. the application for registration of a
traditional herbal medicinal product 100 000 kr
2. the application for registration of a
traditional herbal medicinal products
contains a herbal substance or a
preparation or a combination thereof,
included in the list
drawn up by the European Commission, 50 000 kr
3. the application for recognition of a registration
of a traditional herbal medicines
under the decentralized or it
reciprocal procedure when Sweden are
Member State concerned 32 500 kr
4. Duplikatansökan 30 000 kr
5. the application relating to parallel imported
traditional herbal medicines, 25 000 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name submitted
for the assessment at the same time. The fee for the application for
parallel imported medicinal products as referred to in the first subparagraph 5,
However, all strengths and pharmaceutical form of the same
drug name from the same exporting country that is submitted
for the assessment at the same time.
4 section/entry into force: 01/01/2016
The fee for an application for registration of sale of a traditional herbal medicinal product for human use shall be paid as follows:
1. the application for registration of a traditional herbal medicinal product for 100 000 kr
2. the application for registration of a traditional herbal medicinal product for human use that contains a herbal substance or a preparation or a combination thereof appearing on the list drawn up by the European Commission, 50 000 kr
3. the application for recognition of a registration of a traditional herbal medicinal product for human use in accordance with the decentralised or mutual procedure when Sweden are affected Member country 32 500 kr
4. Duplikatansökan 30 000 kr
5. the application relating to parallel imported traditional herbal medicinal products for 25 000 kr
The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. The fee for application for parallel imported medicinal products pursuant to the first paragraph 5, however, all strengths and pharmaceutical form of the same drug name from the same exporting country that is submitted for assessment at the same time. Regulation (2015:465).
§ 5/expires U: 2016-01-01/
The fee for an application for the extension of an existing
registration of a traditional herbal medicines
amounts to SEK 50,000. For an application for recognition of a
extended registration of a traditional herbal
drugs under the decentralised or mutual
procedure when Sweden are Member State concerned amounts
the fee to 16 250 kr.
§ 5/entry into force: 01/01/2016
The fee for an application for the extension of an existing registration for the sale of a traditional herbal medicinal product for human use is 50 000 kr. For an application for recognition of an expanded registration of a traditional herbal medicinal product for human use in accordance with the decentralised or mutual procedure when Sweden are affected Member country amounts to SEK 16 250 fee Regulation (2015:465).
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The registration of homeopathic medicinal products
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Registration for the sale of homeopathic medicine
6 §/expires U: 2016-01-01/
For an application for registration of homeopathic
medicinal products for human use and veterinary medicinal products,
fee shall be paid as follows:
1. the application for registration of a
homeopathic medicinal products referred to in 2 (b) §
the medicines Act (1992:859) 4 000 kr
2. the application for recognition of a registration
of a homeopathic medicinal products according to the
decentralised or mutual
procedure when Sweden are Member State concerned 2 000 kr
The charge relates to a single simple medium, easy medium in a
dilution series or a composite medium with several
constituents.
6 §/entry into force: 01/01/2016
For an application for registration of sale of homeopathic medicinal products for human and veterinary medicinal products, the fee shall be paid as follows: 1. the application for registration of a homeopathic medicine 4 000 kr
2. the application for recognition of a registration of a homeopathic medicinal products according to the
decentralised or mutual procedure when Sweden are affected Member country 2 000 kr
The charge relates to a single simple means, simple means in a dilution series or a composite medium with more ingredients. Regulation (2015:465).
License and license
paragraph 7 of the licence fee payable under national license
the following:
1. medicinal products for Human use
National (a) application for license) 65 000 kr
b) application for license to meet the
special needs of medicines in individual cases 220 kr
2. Medicinal products for veterinary use
National (a) application for license) 32 500 kr
b) application for license to meet the
special needs of medicines in individual cases 220 kr
Licence for manufacture of medicinal products
section 8/expires U: 2016-01-01/
The fee for an application for authorisation of a professional
the manufacture of medicinal products for human and veterinary
medicinal products shall be paid as follows for each
manufacturing site:
1. The manufacture of medicinal products, with the exception
av 2 65 000 kr
2. Manufacturing of herbal remedies, some
topical medicines, traditional herbal
medicinal or homeopathic medicine 30 000 kr
section 8/entry into force: 01/01/2016
The fee for an application for authorisation of a professional production of medicinal products for human and veterinary use shall be paid as follows for each manufacturing site:
1. The manufacture of medicinal products, with the exception of 2 65 000 kr
2. Manufacturing of herbal remedies, some topical medicines, traditional herbal medicinal or homeopathic medicine 30 000 kr
Regulation (2015:465).
§ 9 the fee for the application for a permit for the establishment of
manufacture of medicines for a particular time
(extemporaneous drug preparations)
1. If the other condition for the production of
medicine is 26 000 SEK
2. If the other condition for the production of
drugs missing 58 500 kr
Authorisation of a clinical drug trial
section 10 of the fee for an application for authorisation to carry out a
clinical trials must be paid with 45 000 kr for
medicinal products for human use and for veterinary 22 500 SEK
medicines.
Chapter 3. Additional listing fees
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Sweden serves as the reference Member State in the
decentralised or mutual procedure
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Sweden serves as the reference Member State in a decentralised or mutual procedure
Authorisation of medicinal products for sale
1 §/expires U: 2016-01-01/
Fee for request to Sweden to work as
the reference Member State in a decentralised or
reciprocal procedure in connection with an application in a different
Member State concerning the authorisation of medicines for sale
shall be paid as follows:
1. medicinal products for Human use
(a)) a request where the product is accompanied by
full documentation 200 000 kr
b) abridged application 200 000 kr
c) request in which the medicinal product is a duplicate
both in Switzerland and in other Member States 30 000 kr
2. Medicinal products for veterinary use
(a)) a request where the product is accompanied by
full documentation 100 000 kr
b) abridged application 100 000 kr
c) request in which the medicinal product is a duplicate
both in Sweden and in another Member State, 15 000 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name in the same request.
In addition to the fee under this section shall charge payable
According to Chapter 2. section 1 of this regulation.
1 section/entry into force: 01/01/2016
Fee for request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a Member State concerning the authorisation of medicines for sale to be paid as follows:
1. medicinal products for Human use (a)) a request where the medicinal product supported by a full dossier 200 000 kr
b) abridged application 200 000 kr
c) request where the medicinal product constitutes a duplicate both in Sweden and in another Member country 30 000 kr
2. veterinary medicinal products (a)) a request where the medicinal product supported by a full dossier 100 000 kr
b) abridged application 100 000 kr
c) request where the medicinal product constitutes a duplicate both in Sweden and in another Member country 15 000 kr
The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug name in the same request.
In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 1 of this regulation. Regulation (2015:465).
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Extension of an existing authorisation
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Extension of an existing authorisation
2 §/expires U: 2016-01-01/
For a request to Sweden to work as
the reference Member State in a decentralised or
reciprocal procedure in connection with an application in a different
Member State concerning the extension of an existing authorisation of
a medicinal product for human use is charge to 200 000 SEK.
a veterinary medicinal product is the fee to
100 000 € Fee applies to all forces and
pharmaceutical form of the same drug name submitted
for the assessment at the same time and for the same type
by amending the conditions for authorisation.
In addition to the fee under this section shall charge payable
According to Chapter 2. section 3 of this regulation.
2 section/entry into force: 01/01/2016
For a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a different Member country on the extension of an existing marketing authorisation of a medicinal product for human use is the fee to $200 For a veterinary medicinal product is the fee to $100 Fee covers all strengths and pharmaceutical form of the same drug names submitted for assessment at the same time and the same type of modification of the conditions for the approval.
In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 3 of this regulation. Regulation (2015:465).
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Registration of herbal medicinal products and
extension of such registration
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Registration for the sale of traditional herbal medicinal products and extension of such registration
3 §/expires U: 2016-01-01/
Fee for a request to Sweden to work as
the reference Member State in a decentralised or
reciprocal procedure in connection with an application in a different
Member State shall be paid as follows:
1. Registration of a traditional
herbal medicine 100 000 kr
2. The extension of a registration of a
traditional herbal medicinal products 50 000 kr
In addition to the fee under this section shall charge payable
According to Chapter 2. 4 and 5 of this regulation.
3 section/entry into force: 01/01/2016
Fee for a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in another Member State shall be paid as follows:
1. Registration of a traditional herbal medicinal product for 100 000 kr
2. The extension of a registration of a traditional herbal medicinal product for 50 000 kr
In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 4 and 5. Regulation (2015:465).
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The registration of homeopathic medicinal products
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Registration for the sale of homeopathic medicine
4 §/expires U: 2016-01-01/
For a request to Sweden to work as
the reference Member State in a decentralised or
reciprocal procedure in connection with an application in a different
Member State on the registration of a homeopathic medicinal product
the fee amounts to 4,000. The same fee applies for
veterinary medicinal products. The charge relates to an individual
simple means, simple means in a dilution series or a
composite products with multiple ingredients.
In addition to the fee under this section shall charge payable
According to Chapter 2. paragraph 6 of this regulation.
4 section/entry into force: 01/01/2016
For a request to Sweden to act as reference Member State in a decentralised or mutual procedure in connection with an application in a Member State for registration of sale of a homeopathic medicine is the fee to £ 400; the same fee applies for veterinary medicinal products. The charge relates to a single simple means, simple means in a dilution series or a composite medium with more ingredients.
In addition to the fee under this section shall charge paid pursuant to Chapter 2. section 6. Regulation (2015:465).
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Modification of an existing authorisation or of a
registration
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Modification of an existing authorisation or a registration for sale
Type II variation of an existing authorisation
§ 5/expires U: 2016-01-01/
For an application for a major variation of type II is
the fee for medicinal products for human and veterinary
medicines to the following amounts in the context of
(a)) the national procedure 10 000 kr
(b)) the reciprocal procedure in Sweden as
reference country 20 000 kr
c) the reciprocal procedure in Sweden as
Member State concerned, 6 000 kr
The fee for all routes of administration, strengths and
pharmaceutical form of the same drug name submitted
for the assessment at the same time.
§ 5/entry into force: 01/01/2016
For an application for a major variation of type II fee amounts for medicinal products for human use and veterinary medicinal products, the following amounts within the framework of a) the national procedure 10 000 kr
(b)) the reciprocal procedure with Sweden as the reference country 20 000 kr
c) the reciprocal procedure in Sweden which affected Member country 6 000 kr
The fee for all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. Regulation (2015:465).
Change of prescription status
6 §/expires U: 2016-01-01/
For a variation of the prescription status according to § 8 g
the medicines Act (1992:859) fee to 100 000
Ad For a veterinary medicinal product is the fee
to 50 000 kr. If the substance has already been the subject of
the same change and product characteristics and package leaflet in all
substantially equal amounts the fee in lieu of 10 000
SEK.
6 §/entry into force: 01/01/2016
For an application for an amended classification in Chapter 4. section 20 of the medicines Act (2015:315) fee to 100 000 SEK.
For a veterinary medicinal product, the fee amounts to € 50 000. If the substance has already been the subject of the same change and product characteristics and package leaflet are essentially equal amounts the charge instead of $1,000.
Regulation (2015:465).
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Type II variation of an existing registration of a
traditional herbal medicinal product or a homeopathic
medicines
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Type II variation of an existing registration for the sale of a traditional herbal medicinal product for human use or a homeopathic medicinal product
section 7/expires U: 2016-01-01/
For an application for a major variation of type II a
the registration fee amounts to the following amounts:
1. Traditional herbal medicinal product under
(a)) the national procedure 10 000 kr
(b)) the reciprocal procedure in Sweden as
Reference Member State 20 000 kr
c) the reciprocal procedure in Sweden as
Member State concerned, 6 000 kr
2. Homeopathic veterinary medicinal products (medicinal products for human use
and veterinary use) 2 000 SEK
To modify an existing registration of a traditional
herbal medicinal product relating to the fee all
routes of administration, pharmaceutical forms, strengths and with
the same drug names submitted for assessment in the same
point in time. For homeopathic medicines refer to the fee a
individual simple means, simple means in a dilution series or
a composite medium with more ingredients.
section 7/entry into force: 01/01/2016
For an application for a major variation of type II of a registration fee for the sale amounts for the following amounts:
1. Traditional herbal medicinal products within the framework of a) the national procedure 10 000 kr
(b)) the reciprocal procedure in Sweden as a reference Member State 20 000 kr
c) the reciprocal procedure in Sweden which affected Member country 6 000 kr
2. Homeopathic veterinary medicinal products (medicinal products for human and veterinary use) 2 000 SEK
To modify an existing registration of a traditional herbal medicinal product for human use refer to charge all routes of administration, pharmaceutical forms, strengths and with the same drug names submitted for assessment at the same time. For homeopathic medicines refer to charge a single simple means, simple means in a dilution series or a composite medium with more ingredients.
Regulation (2015:465).
Chapter 4. Annual fees
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Approved and registered medicines
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Approved and registered medicines for sale
1 §/expires U: 2016-01-01/
The annual fee shall be paid in the following amount:
1. medicinal products for Human use
a) medicinal products for human use, with the exception of the b-h 46 000 kr
b) additional strength and pharmaceutical form,
with the exception of the national license 22 500 SEK
c) duplicate 22 500 SEK
d) traditional herbal medicinal products,
natural remedies and certain topical medications 14 000 kr
e) radiopharmaceuticals and allergens 8 000 kr
f) dilution from the basic extract of allergen
(for each additional dilution) 250 kr
g) homeopathic medicines (for an individual
simple means, simple means in a dilution series
or a composite medium with several
constituents) 250 kr
h) parallel imported medicinal products (per
export country, shape, strength and
approval number) 6 000 kr
2. Medicinal products for veterinary use
a) veterinary medicinal products, with the
the exception of b-f 15 000 kr
b) additional strength and pharmaceutical form,
with the exception of the national licence 7 500 kr
c) duplicate 7 500 kr
d) natural remedies and certain topical medications 14 000 kr
e) homeopathic medicines (for an individual
simple means, simple means in a dilution series
or a composite medium with several
constituents) 250 kr
f) parallel imported medicinal products (per
export country, shape, strength and
approval number) 2 000 SEK
1 section/entry into force: 01/01/2016
The annual fee shall be paid in the following amount:
1. Medicinal products for human use (a)), with the exception of the b-h 46 000 kr
b) additional strength and pharmaceutical form, with the exception of the national license 22 500 SEK
c) duplicate 22 500 SEK
d) traditional herbal medicinal products, herbal remedies and certain topical medications 14 000 kr
e) radiopharmaceuticals and allergens 8 000 kr
f) dilution from the basic extract of allergen (for each additional dilution) 250 kr
g) homeopathic medicines (for a single simple means, simple means in a dilution series or a composite medium with more ingredients) 250 kr
h) parallel imported medicinal products (per country, shape, strength and approval number) 6 000 kr
2. veterinary medicinal products a) veterinary medicinal products, with the exception of (b) – (f) 15 000 kr
b) additional strength and pharmaceutical form, with the exception of the national licence 7 500 kr
c) duplicate 7 500 kr
d) natural remedies and certain topical medications 14 000 kr
e) homeopathic medicines (for a single simple means, simple means in a dilution series or a composite medium with more ingredients) 250 kr
f) parallel imported medicinal products (per country, shape, strength and approval number) 2 000 SEK
Regulation (2015:465).
Manufacturing
section 2 unless otherwise provided for in sections 3 to 5, is the annual fee for
the manufacture of medicinal products for human and veterinary
medicines to 46 000 kr. Fee relating to the manufacture of
a maximum of three pharmaceutical forms. For the production of
additional pharmaceutical forms, a fee of
14 000 SEK per year is paid. In the manufacture of sterile
medicine is also a surcharge of SEK 30 000 per year
paid.
For manufacturing that requires only limited
supervisory input is the annual fee to 14 000 SEK.
3 §/expires U: 2016-01-01/
For the manufacture of medicinal gases, traditional
herbal remedies, natural remedies, some topical
medicinal or homeopathic medicines is the annual fee
to 30 000 SEK for the manufacture of such drugs as
referred to in paragraph 2 (d), the medicines Act (1992:859)
the annual fee amounts to 30 000 SEK per manufacturing authorisations.
For manufacturing that requires only limited enforcement action
the annual fee amounts to 14 000 SEK.
The same fees as specified in the first and second paragraphs applies
for veterinary medicinal products. Regulation (2011:236).
3 section/entry into force: 01/01/2016
For the manufacture of medicinal gases, traditional herbal medicinal products, herbal remedies, some topical medications or homeopathic medicines is the annual fee to $30 000 for the manufacture of a medicinal product covered by a hospital except the annual fee amounts to 30 000 SEK per manufacturing authorisations.
For manufacturing that requires only limited enforcement effort is the annual fee to 14 000 SEK.
The same fees as specified in the first and second subparagraphs shall apply to veterinary medicinal products. Regulation (2015:465).
4 section for the manufacture of radiopharmaceuticals to hospitals or
medicines for dialysis treatment is the annual fee for
14 000 kr. The same fee applies for veterinary
medicines.
§ 5/expires U: 2016-01-01/
For the establishment for the manufacture of pharmaceutical products for a
particular time (extemporaneous drug preparations), the annual fee for
32 500 kr in cases where the other condition for manufacturing
missing. In the case of the other conditions for production are
the fee amounts to 13 000 kr.
§ 5/entry into force: 01/01/2016
For an annual fee to the extemporaneous drug preparations is 32 500 kr
in cases where the other condition of manufacture are missing. In the case of the other conditions for the manufacture, see fee amounts to 13 000 kr. Regulation (2015:465).
Chapter 5. Special charges
Scientific advice
section 1 the fee for the application for scientific advice is
to 45 000 kr.
Certificate
section 2 of the fee for the application for a certificate of authorization to manufacture
medicinal products and applications for the export of medicines
amounts to 950 kr.
paragraph 3 of the Fee for the issuance of the certificate of inspection of
production batch with respect to vaccines and blood products for
human use before release on the Swedish market in
cases where European certificate for batch release missing amounts
to $200.
Fee for the application for a certificate for the export of certain
batch of drug is 2 000 SEK.
Chapter 6. Payment of fees
Payment of the application fee, additional fee and
special fee
section 1 of the application fee, additional fee and special
fee must be paid by the applicant.
Payment of the annual fee
2 §/expires U: 2016-01-01/
The annual fee to be paid for:
1. the authorisation of medicinal products for sale: by
the holder of the authorisation as from the month following the
When the drug was approved for sale to the
year in which the marketing authorisation ceases to be valid,
2. registration of traditional herbal medicinal product:
the holder of the registration as of the month following the
the time the drug was registered until the year in which the
registration expires,
3. registration of homeopathic medicines: by the holder
of the registration from the year in which the product
registered until the year in which registration ceases
to apply,
4. manufacturing of pharmaceutical products: the holder of the
State as of the month following that in which
manufacturing authorization was announced until the year in which the
it expires.
Annual fee provided for in the first subparagraph 1 to 3 shall not be paid if
the medicine deregistered by 31 January.
2 section/entry into force: 01/01/2016
The annual fee to be paid for:
1. the authorisation of medicinal products for sale: by the mAh from the month following that in which the drug was approved for sale through the year in which the marketing authorisation ceases to be valid,
2. registration of traditional herbal medicinal products for sale: by the holder of the registration as of the month following that in which the product was registered for the year in which the registration expires;
3. registration of homeopathic medicinal products for sale: by the holder of the registration from the year in which the product was registered until the year in which the registration expires;
4. manufacturing of pharmaceutical products: by the permit holder as of the month following that during which the manufacturing authorization was given to the year in which the authorization expires.
Annual fee provided for in the first subparagraph 1 to 3 shall not be paid if the medicine deregistered by 31 January.
Regulation (2015:465).
paragraph 3 of the Fee payable to the Agency for
Special billing.
section 4 of the food and Drug Administration may, if there are special reasons, in
each case repay or reduce all
or part of a fee.
Chapter 7. Other provisions
Authorization
section 1 the Agency may notify the rules
necessary for enforcement of this regulation.
/Rubriken expires U: 2016-01-01/
Appeal
2 §/expire U:2016-01-01 by Regulation (2015:465)./
In 22 a of the Administrative Procedure Act (1986:223) is
provisions for an appeal to the public
Administrative Court.
Transitional provisions
2010:1167
1. This Regulation shall enter into force on January 1, 2011, when
Regulation (1993:595) on charges for the State
the control of medicines shall be repealed.
2. The repealed regulation continues to apply in respect of
fees relating to the period prior to the entry into force.